An interventional study of TUBSIS 2.0 in Tobacco Use Disorder, Nicotine Dependence and Vaping, sponsored by University of Zurich. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Zurich · Not applicable, Interventional, and Treatment
Background:
Tobacco smoking and vaping remains public health concern, with many adults continuing to experience difficulties accessing appropriate support for smoking cessation in Switzerland and Türkiye. Structural barriers, including stigma related to attempting to quit, limited financial and time resources, low awareness of the health risks associated with tobacco smoking- and vaping-reduce engagement with traditional services. TUBSIS 2.0 aims to address these access inequities by providing a fully remote, anonymous and free internet-based program tailored to diverse adult populations in both countries.
Objectives:
The "TUBSIS 2.0: An Adaptation Study of Tobacco Addiction Support Programme - TUBSIS for Tobacco Users in Switzerland and Türkiye" project aims to support readiness to reduce or quit tobacco smoking/vaping, improve well-being and self-compassion and strengthen health-related behaviors. The intervention targets German-, English-, and Turkish-speaking adults and includes mindfulness-based strategies for quitting or reducing tobacco smoking and vaping. Motivation to cease tobacco smoking/vaping varies considerably across the lifespan. Younger individuals may perceive smoking/vaping cessation as unnecessary, often due to limited awareness of long-term health risks or a sense of invulnerability. In later adulthood, although addiction tends to be more deeply established, many individuals hesitate to attempt cessation because of concerns about the psychological and behavioral challenges associated with the process. It is therefore essential to provide individuals with support that helps them understand the cessation process, prepare for the challenges that can be expected and identify strategies that align with their psychological needs. Such strategies may include stress management and self-compassion practices that can be utilized before, during and after cessation attempts. TUBSIS 2.0 offers structured and accessible guidance to support this preparation by providing a clear, evidence-based pathway for individuals at different stages of readiness to change.
Methods:
TUBSIS 2.0 is a web-based, individual and asynchronous program consisting of eight modules delivered over four weeks. A total of 406 participants will be recruited and randomly assigned to either the intervention or control group. Data are collected anonymously at four measurement points (baseline, mid-term, post-term and 8-week follow-up) from participants. The program focuses on supporting participants' reducing or quitting tobacco smoking or vaping; to increase their readiness for smoking/vaping cessation, mental well-being, self-compassion and stress management with mindfulness strategies.
Within the Health Action Process Approach (HAPA), the process of behaviour change is conceptualised as a dynamic, non-linear process that progresses through motivational and volitional phases. TUBSIS 2.0 has been adapted to reflect this structure by integrating phase-specific components. These components include modules that enhance risk awareness and outcome expectancies, planning and self-regulation tools to support action initiation and mindfulness-based strategies that are embedded throughout all phases to strengthen self-efficacy and coping. By addressing these shifting needs across the change process, the programme provides a responsive and theory-driven pathway for reducing/quitting tobacco smoking or vaping.
Relevance:
TUBSIS 2.0 is highly relevant to public health priorities, as it provides a cost-effective, scalable and environmentally sustainable intervention that eliminates barriers commonly associated with traditional cessation services. By requiring no travel, printed materials or in-person appointments, the programme offers equitable access to adults across all age groups, genders and diverse migrant communities in Switzerland and Türkiye. Its multilingual and culturally adapted structure addresses significant service gaps for populations that are underserved or hesitant to seek conventional support. By reducing tobacco smoking- or vaping-related harm and facilitating early behavioural change, TUBSIS 2.0 has the potential to decrease long-term healthcare costs while expanding access to evidence-based digital prevention tools.
TUBSIS 2.0 is a culturally adapted, digital psychoeducation and behavior change intervention that integrates principles from the Health Action Process Approach (HAPA), mindfulness, and self-compassion. The program aims to support participants in increasing mental well-being, enhancing self-regulation, and facilitating progression through stages of behavior change related to tobacco use.
The intervention consists of eight structured modules delivered over a four-week period. Each module includes brief psychoeducational content, guided exercises, and reflective components targeting awareness of smoking behavior, coping with cravings, stress management, and goal setting. Participants are encouraged to engage with the modules flexibly and at their own pace.
Participants are randomly assigned to either an intervention group or a control group. The intervention group receives immediate access to the TUBSIS 2.0 program, while the control group is placed on a waitlist and receives access after a defined follow-up period.
Data are collected at multiple time points, including baseline, mid-intervention, post-intervention, and follow-up assessments. Primary outcomes include changes in stage of behavior change, tobacco consumption patterns, and point prevalence abstinence. Secondary outcomes include mental well-being and nicotine dependence.
The study is conducted fully online, and participation is voluntary and anonymous. The design aims to minimize participant burden by using short modules and brief assessments while maintaining methodological rigor.
1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's planned enrollment of 406 is above the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Smoked on ≥1 day in the past 30 days, and/or Smoked at least 100 cigarettes in lifetime
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive immediate access to the TUBSIS 2.0 web-based behavioral intervention program designed to support "smoking tobacco use or vaping reduction" through psychoeducation, mindfulness and behavior change techniques.
Behavioral: TUBSIS 2.0
Participants are assigned to a waitlist control group and receive access to the intervention after a defined follow-up period.
A web-based, asynchronous behavioral intervention program integrating psychoeducation, mindfulness, and behavior change techniques to support tobacco and e-cigarette use reduction. The program consists of structured modules delivered over a four-week period and includes exercises targeting self-regulation, craving management, and motivation for behavior change.
7-day point prevalence abstinence
Self-reported abstinence from smoking/vaping (not having smoked/vaped even one puff in the past 7 days).
Time frame: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Cigarette/vapor consumption
Change in cigarette/vapor consumption measured as number of cigarettes smoked or vaping per day for daily smokers and frequency and quantity of smoking for occasional smokers.
Time frame: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Stage of behavior change
Change in stage of behavior change according to the Health Action Process Approach (pre-intender, intender, actor).
Time frame: 4 weeks (post-intervention) + 4 weeks
Mental well-being
Change in mental well-being measured using the Warwick-Edinburgh Mental Well-Being Scale - Short Form. Scores range from 7 to 35, with higher scores indicating better mental well-being.
Time frame: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Nicotine dependence (Fagerström Test for Nicotine Dependence)
Change in nicotine dependence measured using the Fagerström Test for Nicotine Dependence. Scores range from 0 to 10, with higher scores indicating higher nicotine dependence.
Time frame: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Nicotine dependence (Electronic Fagerström Test for Nicotine Dependence)
Change in nicotine dependence measured using the Electronic Fagerström Test for Nicotine Dependence. Scores range from 0 to 10, with higher scores indicating higher nicotine dependence.
Time frame: 4 weeks (post-intervention) + 4 weeks (follow-up without intervention)
Plan to share: No — Individual participant data will not be shared due to data protection regulations and the sensitive nature of the collected data.
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